Arixtra (fondaparinux sodium)
- Region
- 🇪🇺 EU
- Active substance
- fondaparinux sodium
- Company
- Viatris Healthcare Limited
- Status
- Authorised
- Therapeutic area
- Venous Thrombosis; Pulmonary Embolism; Myocardial Infarction; Angina, Unstable
- CHMP opinion
- Thu 22 Jul 2010
- EU approval
- Wed 20 Mar 2002
- Application
- EMEA/H/C/000403
- ATC
- B01AX05
- Official record
- www.ema.europa.eu
Indication
1.5-mg/0.3-ml and 2.5-mg/0.5-ml solution for injection Prevention of venous thromboembolic events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery. Prevention of VTE in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery. Prevention of VTE in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and / or acute respiratory disorders, and / or acute infectious or inflammatory disease. Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis. 2.5-mg/0.5-ml solution for injection Treatment of unstable angina or non-ST-segment-elevation myocardial infarction (UA/NSTEMI) in adult patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated. infarction (STEMI) in adult patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy. 5-mg/0.4-ml, 7.5-mg/0.6-ml and 10-mg/0.8-ml solution for injection Treatment of adults with acute deep-vein thrombosis (DVT) and treatment of acute pulmonary embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.
Regulatory milestones
Arixtra (fondaparinux sodium): DHPC sent to healthcare professionals
Quality defect; Venous Thrombosis, Pulmonary Embolism, Myocardial Infarction, Angina, Unstable · source
Same substance in other markets
- 🇪🇺 Fondaparinux sodium Evumed Opinion · Evumed Limited
- 🇪🇺 Quixidar Withdrawn · Glaxo Group Ltd.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.